Comparison of Figure-Of-Eight Suture and Perclose ProGlide Suture-Mediated Closure System in Achieving Hemostasis After a Large Bore Venous Access.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Hemostasis Time
研究概览
简要总结
The study proposes to compare specialized closure devices to achieve hemostasis with the Figure-of-eight suture technique.
详细描述
Procedures where patients requiring large bore venous access will be randomized 1:1 to either the Figure-of-eight suture technique or the Perclose Device to achieve hemostasis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients who successfully undergo venous large bore access sheath placement for structural heart procedures.
排除标准
- •Patients who do not consent
- •Minors or those unable to consent
研究组 & 干预措施
Figure-of-eight
Using the figure-of-eight closure technique when closing access for structural heart therapies.
干预措施: Figure-of-eight suture (Other)
Perclose Device
Using the Perclose device when closing access for structural heart therapies.
干预措施: Perclose Device (Other)
结局指标
主要结局
Hemostasis Time
时间窗: Immediate
To assess if an additional device use to achieve hemostasis can be avoided after a large bore venous access
Procedure Time
时间窗: Immediate
Access Site Complication
时间窗: 1 month
次要结局
未报告次要终点
研究者
Houman Khalili MD
Principal Investigator
Delray Medical Center